With existing floors packed with equipment to capacity, the arrival of highly-potent API drugs or reranking OEL values of existing API’s poses a dilemma. These potent compounds require equipment with higher Occupational Exposure Band (OEB) values, pushing the facility’s capabilities to the limit.

For API’s up to OEB3 equipment, standard equipment such as downflow booths for weighing and specially modified local extraction units for dispensing (depending on the specific process) will be sufficient. But beyond that threshold, creativity and innovative design are required to incorporate the additional or modified installations.  A multi-tiered approach is needed to mitigate operator exposure.

By grouping different process approaches in overall strategies for OEB 4 API’s or higher situations  you are able to support overall process solutions within a  facility such as:

• Small amount of High-API (0 – 5 kg) weighed in an isolator dispensed as solids or pre-soluted in specific isolators before dispensing;
• High amounts of High-API (50 -500 kg or more) dosed as solids with “high throughput”;
• A combination of above strategies to cover all situations.

In order to find the optimal solution for each strategy a multidisciplinary team effort is needed to answer questions like:

• What is possible from a Regulatory; Product; Process; EHS; Operations; Engineering; Logistic and Cost perspective?
• For which specific situations and installations should a mock-up be built, or should the process be mimicked with the operators / engineers and EHS in place to find the optimal solution and create a supporting base within the customers’ organization?
• How can we test and finetune the upgraded process? Standardized testing methods (such as Dust-track analyses) proved inadequate for measuring the efficacy of the upgraded manufacturing process for OEB4 processes or higher.